The President signed a decree on measures to support the pharmaceutical industry

Uzbekistan intends to provide 80% of the drug market with its own products by 2026. The corresponding decree was signed by Shavkat Mirziyoyev.

This document approves a targeted program of investment projects implemented in the pharmaceutical industry for the next 5 years, as well as a list of projects that need to be finalized. During this time, it is planned to increase the volume of drug production by 3 times.

The implementation of these projects will be monitored by a special commission led by the head of the MIFT, Sardor Umurzakov. It will also be able to replenish and change the list of investment projects implemented in the targeted program.

From April 1, registration in Uzbekistan of new pharmaceutical products of local production will become indefinite. Previously issued registration certificates upon expiration of their validity period will be exchanged for unlimited ones within 15 days.

In addition, from April 1, a mechanism for guaranteed purchase of localized pharmaceutical products at the expense of the state budget is being introduced. For this, a special contract for 3 years will be concluded.

Suppliers for guaranteed purchases will be selected through an open tender. These competitions are held as part of the list of medicines, medical devices and medical equipment that were not previously produced in Uzbekistan and are subject to localization.

A number of restrictions in the pharmaceutical industry are canceled:

• a ban on private organizations to collect donated blood and produce pharmaceutical products based on it;
• restriction on conducting clinical trials of drugs on healthy volunteers;
• restriction on the production of drugs with the same composition by one manufacturer under different trade names.

New pharmaceutical companies – manufacturing and trading enterprises – from April 1 will be created in accordance with the requirements of good practices (GxP). The mandatory GxP certification period is extended until January 1, 2024.

At the same time, from January 1, 2023, only certified suppliers are allowed to public procurement :

• drug manufacturers – according to the GMP standard;
• suppliers of medical equipment and other medical products – according to ISO: 13485;
• wholesale pharmaceutical distributors – according to the GDP standard.

In addition, exporters of pharmaceutical products operating under GMP standards will receive benefits:

• subsidies to cover up to 50% of export-related costs (up to 5% of the total export value when transported by road, up to 7% by rail);
• revolving loans for replenishment of working capital – for a period of up to 1 year, at 4%, up to $ 3 million.

Until January 1, 2025, the following are exempt from customs duties:

• raw materials, materials, medical products used for pharmaceutical production and preclinical studies;
• technological and laboratory equipment, components and spare parts for them, “clean rooms”, sandwich panels and ventilation systems for pharmaceutical production facilities.

 

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